[Hiring] Director of Clinical Safety and Medical Monitoring @NAMSA

Role Description

• Actively works to promote operational excellence by monitoring and improving processes related to management of Individual Safety Case Reports of Adverse Events / Serious Adverse Events (ICSRs), Clinical Events Committees (CECs), and Data Monitoring Committees (DMCs).
• Develops and/or maintains knowledge of current Good Clinical Practices, Good Vigilance Practices, Safety best writing practices, and data entry conventions.
• Acts as a leader and mentor to Safety team members and non-Safety staff. Develops individualized training plans for new hires and onboards incoming staff to Safety department.
• Accomplishes department financial objectives by assisting with forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
• Maintains qualified staff by recruiting, selecting, orienting, and training Associates, and developing personal growth opportunities via training plans, quality oversight/assurance and/or career path planning.
• Allocates workload for client projects.
• Models and instills exceptional customer service across the team by acting collaboratively, being responsive to client requests, communicating thoughtfully, and maintaining high standards of quality.
• Seeks opportunities to work cross-functionally to provide solutions to clients within the context of client projects, business strategy, and internal initiatives.
• In collaboration with Finance and Senior Leadership, solves issues related to financial objectives for department.
• Provides content and/or review of departmental Standard Operating Procedures, work instructions, forms, training materials, guides, and templates.
• In collaboration with other Safety Management, identifies departmental or Company-level risks and executes mitigation plans.
• Attends company management meetings to provide Safety departmental and project updates upon request.
• Participates in developing departmental key performance/quality indicator metrics, staff performance evaluation documentation, and performance improvement plans.
• Supports Safety study team members in creating project plans and charters based on study protocol and sponsor requirements. Acts as first point of escalation within the Safety department for study-related sponsor questions/concerns. Attends study team meetings as needed to support assigned Safety team members.
• Supports Safety team members in tracking incoming ICSR reports to ensure all case versions are processed according to project documents and protocol requirements.
• Reviews and quality checks Safety reports prepared by assigned Safety team members prior to sponsor review and regulatory submission, including ICSR reports and periodic aggregate data reports. May delegate quality control work for Pharmacovigilance ICSR case processing to Safety team members as needed.
• Represents Safety department in quality assurance activities including internal audits, sponsor audits, and regulatory inspections.
• Represents Safety department during business development opportunities upon request or as a backup to Head of Safety.
• Supports revenue forecasting, Sponsor invoicing, and study budget management for Safety department.
• Complies with the Medical Team Roles and Responsibilities.
• Supports NAMSA’s internal and client-based activities and serves as a scientific technical and/or strategic consultant to clients at their request. Examples include:
  • Collaborate with clients to develop product development strategy.
  • Support clients in developing clinical, scientific, and/or regulatory strategies and contribute to interactions with global regulatory agencies. This could include, but is not limited to, FDA (including advisory committee preparation), pre-submission meetings, and assisting with strategic approaches regarding the use of data.
  • Support and contribute to medical writing activities, which may include: author and/or review manuscripts, abstracts, and presentations; conduct literature reviews; collect and analyze data; author and/or review clinical evaluation plans, clinical evaluation reports, clinical study protocols, and clinical study reports.
• Understands and seeks additional knowledge of all NAMSA business segments to be able to advise clients on the full scope of NAMSA services.
• Prepares written documents including protocols, final reports, SOPs, worksheets, and other associated documents. Reviews and signs protocols and reports for studies.
• Serves as key liaison with clients, including communications in critical and high-profile discussions with upper and executive level management.
• Understands the complexity of multiple moving pieces within the project execution, motivates the team, and collaborates with the client to adjust plans in order to optimize performance.
• Acts with flexibility, transparency, and proactively mitigates business and project risks.
• Effectively achieves high quality and successful project completion.
• Persuasively influences clients and internal stakeholders regarding scientific and/or strategic aspects of project support.
• Medical supervisory roles for safety, medical writing, regulatory.
• Assists with Business Development responsibilities.
• Works with Biostats in the construction of TLF shells, reviews when complete.

Qualifications

• Doctor of Medicine degree and postgraduate training from an accredited institution.
• At least 5 years of relevant experience.
• Current medical license preferred.
• Strong interest in Science, Mathematics, and Healthcare.
• Knowledge of the MedTech industry.
• Strong leadership and communication skills.
• Must be able to work independently.
• Strong organizational skills with attention to detail.
• Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Science.
• Demonstrate a high degree of personal and professional integrity.
• Willingness to travel as necessary for conferences and client meetings.
• Knowledge of and experience with Microsoft Word, Excel and other medical writing tools.
• Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.

Working Conditions

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.

Compensation

The compensation grade range for this position is: $152,300.00 - $296,600.00 annually. Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.